Ireland’s thriving life sciences sector offers significant opportunities for global medicinal products and medical device manufacturers, supported by a strong innovation ecosystem and access to EU markets.
The Health Products Regulatory Authority (HPRA) is the competent authority responsible for regulating medicines, medical devices, and other health products in Ireland — overseeing registrations, licensing, clinical trials, pharmacovigilance, and post-market compliance. MedWisdom LifeScience provides comprehensive end-to-end Regulatory Affairs services to help foreign manufacturers navigate Ireland’s regulatory requirements efficiently, secure timely approvals, and achieve sustained compliance in this dynamic market.
Get Ireland Compliance Support
Tailored strategic advice on Irish and EU regulatory pathways to optimize market entry and long-term success.
Up-to-date regulatory intelligence, HPRA liaison, and proactive guidance on evolving requirements for medicines and devices.
Support for national, MRP, DCP, and centralized procedures, including license transfers and maintenance.
Full operational assistance from initial planning through submission, approval, and ongoing compliance management.
Preparation and management of high-quality submissions to HPRA and EMA, including variations and renewals.
Expert CTD/eCTD/NeeS dossier compilation, scientific advice preparation, and quality review for successful approvals.
Securing and maintaining marketing authorizations, acting as local representative, and license holder support in Ireland.
PMS/PMSR plans, vigilance reporting, trend analysis, FSCA notifications, and HPRA compliance for devices and medicines.
Irish/English labeling review, Blue Box requirements, mock-up preparation, readability testing, and updates.
Partner with Medwisdom for expert, streamlined, and fully compliant regulatory support in Ireland — from strategic consulting and dossier preparation to market authorization and post-market success.
Contact Our Ireland Regulatory Experts